The present invention relates generally to externally applied male urinary catheters. More particularly, the present invention relates to a self-adhesive external male urinary catheter that is easily applied and fits all patients.
Most external male urine collection devices are roll-on condom-like devices. Historically, the first external male catheters were made from condoms with an attached tubular terminus. Improvements in the basic design include reinforcement of the distal end of the catheter, incorporation of a bulb stem to prevent twisting or kinking of the distal end as described in the Klug, et al. U.S. Pat. No. 4,846,909, and the addition of adhesive for ease in application as described in the Conway, et al. U.S. Pat. No. Re. 33,206.
Even with these improvements, however, roll-on-type catheters have several limitations.
First, the greatest difficulty is encountered in applying the roll-on-type catheter. The rolled condom catheter is pushed against the head of the penis to unroll the catheter onto the penis. This has the effect of compressing the penis against the abdomen which reduces or eliminates the penile shaft onto which the catheter must be unrolled.
Second, the presence of adhesive on the condom catheter makes application more difficult. Application of a conventional condom catheter requires one hand to grip the penis head and elongate the penis shaft, and the other hand to roll the catheter onto the elongated penis. If the condom catheter is used with adhesive, great manual dexterity is required to apply the double-sided tape or unroll the self-adhesive catheter. Invariably, the care giver's fingers become entrapped in the adhesive, the penis cannot properly be manipulated and, therefore, shortens in length, and since the penis is flaccid, it is extremely awkward to unroll the device.
Third, numerous sizes are required for a proper fit on various sized penises. When a conventional condom catheter is unrolled onto the penis, there is often an unrolled portion left at the base of the penis. This unrolled portion constricts and hinders blood circulation in the penis, and is uncomfortable for the patient during an involuntary erection. It is common practice to cut away the rolled portion that is left after the catheter has been applied. In addition, the condom catheter's diameter will be too small for some patients, causing discomfort, and too large for some patients, leading to fluid leakage from the catheter. Thus, it is improbable for both the length and diameter of the roll-on condom catheter to fit various patients without manufacturing numerous sizes.
Fourth, application of a roll-on condom catheter requires extensive positioning and handling of the male penis by the care giver. Loss of hygiene and disease contagion due to touching the male appendage is a paramount concern to today's care giver. The skin of the penis is often broken; this situation is worsened by repeated application of the roll-on-type catheter. In addition, semen or other body fluids may be present on the penis. Using gloves. to minimize risk of disease contagion. makes application of the condom catheter difficult due to the use of adhesive, mentioned previously.
To remedy the difficult of proper fit, U.S. Pat. No. 3,788,324 provided a non-roll-on catheter having a single slit running the length of the condom catheter sheath. However, the device disclosed in this patent does not have overlapping flaps and, therefore, does not realistically deal with the previously listed limitations; preventing backflow of urine, leakage of urine from the slit, and difficulty in application.